Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure
NIV
1 other identifier
interventional
51
1 country
1
Brief Summary
In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 20, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedApril 22, 2009
April 1, 2009
1.8 years
April 20, 2009
April 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications
30 days after enrollment
Secondary Outcomes (1)
out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure
30 days after enrollment
Study Arms (2)
1
ACTIVE COMPARATOR"Non-invasive ventilation"
2
ACTIVE COMPARATOR"Conventional"
Interventions
increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
Eligibility Criteria
You may qualify if:
- acute respiratory failure
- at least 18 years old
- cooperative
You may not qualify if:
- cardiac arrest
- respiratory arrest
- unconscious
- uncontrollable agitation
- less than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EMS
Göttingen, Lower Saxony, 37073, Germany
Related Publications (1)
Roessler M. [Non-invasive ventilation in prehospital emergency medicine]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2008 Apr;43(4):264-6. doi: 10.1055/s-2008-1076608. German.
PMID: 18409119BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC
Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 20, 2009
First Posted
April 22, 2009
Study Start
March 1, 2005
Primary Completion
January 1, 2007
Study Completion
April 1, 2009
Last Updated
April 22, 2009
Record last verified: 2009-04